Kornimate/medical-research-clean huggingface dataset:
recurrence monitoring in nsclc using circulating tumor dna

Conditions: Non Small Cell Lung Cancer

Summary: this research study is investigating the role of cell free tumor dna profiling in determining disease relapse and/or progression for patients with advanced nsclc.

the objective of this study is to determine the ability of cell free tumor dna genomic profiling to predict disease relapse or progression while on therapy for advanced stage nsclc in comparison to current standard objective measures of disease relapse or progression. this study is a prospective observational study. the investigators will assess whole genome sequencing from patient blood samples collected alongside routine blood draws with each treatment cycle to determine the tumor load score at each timepoint while on therapy. ct images will be obtained at routinely ordered timepoints throughout therapy and will be used in the assessment for standard clinical or radiographic evidence of disease progression. these methods of measuring disease progression will be compared in a lead time analysis.

Eligibility criteria:
inclusion criteria: * treatment naïve biopsy confirmed not surgically resectable stage iii or greater nsclc * baseline ct imaging available exclusion criteria: * patients unable to undergo biopsy for initial tissue diagnosis * patients who do not wish to pursue standard of care therapy * patients with another diagnosis of malignancy
evaluation of the therapeutic benefit of r-methuifn- gamma in aids patients with disseminated mycobacterium avium-intracellulare (mai) infection: a multi-centered pilot study

Conditions: Mycobacterium Avium-Intracellulare Infection; HIV Infections

Summary: to examine the effectiveness of subcutaneous gamma interferon in reducing severity of mycobacterium avium- intracellulare (mai) bacillemia episodes in aids patients in an open-label dose-randomized multi-center pilot clinical investigation. to evaluate the safety of gamma interferon given by subcutaneous injection (sc) in the aids patient in the presence and absence of azt therapy.


Eligibility criteria:
inclusion criteria patients must have: * diagnosis of aids and persistent mycobacterium avium- intracellulare (mai) bacillemia. * life expectancy of at least 3 months. * baseline chest x-ray and ekg (electrocardiogram). exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * known hypersensitivity to interferons or other exogenous lymphokine. * history of cardiac abnormality or disease. * history of hypertension. patients with the following are excluded: * known hypersensitivity to interferons or other exogenous lymphokine. * history of cardiac abnormality or disease. * history of hypertension. prior medication: excluded within 4 weeks of study entry: * corticosteroids. * anti-inflammatory medication (except aspirin). * changes in the dose of anti-mycobacterial drugs. * immune agents. prior treatment: excluded within 4 weeks of study entry: * radiotherapy. risk behavior: excluded: * intravenous drug abuse.

Keywords: aids-related opportunistic infections mycobacterium avium-intracellulare infection interferon-gamma, recombinant acquired immunodeficiency syndrome
the 3-dimensional ultrasound for fetal anomaly scan

Conditions: Pregnancy

Summary: the aim of this study is 1) to study the clinical application of 3d/4d ultrasound for fetal scanning during pregnancy; 2) ) to study the clinical application of 3d/4d ultrasound for pelvic scanning; 3) to demonstrate how to optimally display the different organs. 4) to correlate our findings with other diagnostic tools like mri, ct; 5) to correlate our findings with clinical outcome.

a prospective studies of patients that coming to the ultrasound (us) unit in sheba medical center from november 2007 for diagnostic us examination. patients will receive information of the study (printed and oral) and will ask to sign informed consent to act as a research subject and permission to use personal heath information for research. studies is performed using commercially available ultrasound equipment (voluson 730 expert, general electric healthcare, kretztechnik, zipf, austria) with volumetric abdominal rab 4-8 mhz and volumetric transvaginal ric 5-9 mhz transducer probes. during the examination of the patient pictures and 3d/4d volumes will acquired either by static 3d or 4d volume or stic (spacio temporal image corelation), contrast imaging in plane c (vci-c) with and without doppler (color, power and high definition) and with b-flow. image quality will be assessed in various modes. for optimizing the image volumes manipulations will be performed by positioning of the

Eligibility criteria:
inclusion criteria: * pregnant woman who come for fetal anomaly scan. exclusion criteria: -

Keywords: to study the clinical application of 3d/4d ultrasound for fetal scanning to study the clinical application of 3d/4d ultrasound for pelvic scanning; to demonstrate how to optimally display the different organs. to correlate our findings with other diagnostic tools like mri, ct; to correlate our findings with clinical outcome.
immunogenicity and safety of inactivated vero cell derived japanese encephalitis vaccine in thai children

Conditions: Encephalitis, Japanese B

Summary: japanese encephalitis (je) is the main cause of viral encephalitis in many countries of asia including thailand. estimated annual mortality ranges from10,000-15,000 deaths, while the total number of clinical cases is about 50,000. of these cases, about 50% result in permanent neuropsychiatric sequelae. the disease occurs mostly among children aged \<10 years. there is no specific antiviral treatment for je. vaccination is the single most important control measure. this study aims to evaluate the immunogenicity and safety of inactivated vero cell derived je vaccine (beijing p-3 strain) produced by liaoning cheng da biotechnology co., ltd, china "jevac" in thai children. 152 healthy thai children aged between 1-3 years will be vaccinated with "jevac" in a dose of 0.5 ml. subcutaneously on day 0, 1-4 weeks later and a booster vaccination at one year (totally 3 doses). two ml. of blood will be drawn on day 0, 4 weeks after second dose, at one year on booster vaccination day and 4 weeks after the booster (totally 8 ml. of 13 months study period) for determination of je neutralizing antibodies (prnt50) using beijing p3 strain. adverse events will be observed for 28 days after each vaccination. serious adverse events will be observed throughout the study period.


Eligibility criteria:
inclusion criteria: 1. healthy thai children aged 1- 3 years 2. no previous history of je vaccination 3. available for all visited schedule in the study period. 4. written inform consent signed by a parent or guardian exclusion criteria: 1. known serious underlying diseases such as nervous system, heart, kidney and liver diseases. 2. known hypersensitivity to je vaccine composition such as human albumin, dextran 40, etc. 3. previous history of je disease. 4. receive the blood component within the past 3 months, 5. known history of immunocompromised conditions such as hiv/aids, malignancy. 6. under treatment of immunosuppressive drugs such as systemic corticosteroid and anti-neoplastic drug. 7. febrile illness (temperature ≥37.5°c) or acute illness/infection on the day of vaccination 8. plan to leave the study area before the end of study period. 9. participating in other clinical trials.

Keywords: inactivated japanese encephalitis vaccine vero cell children immunogenicity safety
impact and use of abatacept iv for rheumatoid arthritis in real life setting

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to assess abatacept intravenous (iv) effectiveness in patients with inadequate response to one or more conventional disease modifying against rheumatism (dmards) including methotrexate in france, through the estimation of abatacept retention rate over 2 years and reasons of discontinuation

observational model: other: reaction is a study using secondary data originally collected in action study. in action, data were collected prospectively from october 2010 up to 2015 at each clinical visit. in france, data collection started in june 2011

Eligibility criteria:
inclusion criteria: - all patients enrolled in action with inadequate response to one or more conventional dmards including methotrexate and treated with abatacept iv will be included in reaction action inclusion criteria for france were: * male or female subjects of more than 18 years old * patients with a diagnosis of established moderate to severe active ra * patients who at their physician's discretion are treated with abatacept (initiated or already on treatment within 3 months) according to routine clinical practice * patients for whom baseline characteristics are available * patients consent for usage of their data in action study * patients who were not included in any interventional clinical trial in ra
comparison of the effect of liraglutide in young versus elderly healthy volunteers

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to compare the exposure of liraglutide in young versus elderly healthy subjects.


Eligibility criteria:
inclusion criteria: * good general health as judged by the investigator, based on medical history, physical examination including 12-lead ecg (electrocardiogram), vital signs, and blood and urinary laboratory assessments * age, young subjects: age 18-45 years (both incl.) * age, elderly subjects: age at least 65 years * body mass index (bmi) 18-30 kg/m\^2 (both incl.) * blood pressure, young: diastolic 50-90 mmhg, systolic 90-140 mmhg * blood pressure, elderly: diastolic 50-95 mmhg, systolic 92-160 mmhg exclusion criteria: * history of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease, or other major disorders that could interfere with the objectives of the trial, as judged by the investigator * impaired renal function * any clinically significant abnormal ecg (electrocardiogram) * active hepatitis b and/or active hepatitis c * positive hiv (human immunodeficiency virus) antibodies * febrile illness within 5 days prior to first administration of liraglutide * history of alcoholism or drug abuse during the last 12 months * smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products * habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator
assessing mixed reality for emergency medical care delivery in a simulated environment

Conditions: Emergency Medicine

Summary: this study assessed the feasibility and effectiveness of using mixed reality (mr) through the use of hololens2tm technology to enhance emergency clinical care delivery in a simulated environment. this was achieved by inviting 22 resident grade doctors to complete two scenarios. each scenario was supported either by standard care methods or mixed reality. the participants were randomised to at the start of the scenarios to determine which support they would receive first. the main outcome was to see if there was difference in error rates. this was assessed using the icecap multidimensional error capture tool. secondary outcomes included teamwork, scenario completion, stress/cognitive load, and mixed reality device user acceptability.


Eligibility criteria:
inclusion criteria: * all participants must provide consent to participate in the study * participants must receive a standardised hl2 headset and operational tutorial * participants must complete a qualitative questionnaire to determine their clinical experience and exposure to the technology prior to commencement of the study * participants must pass a competency test to ensure standardised basic technical competency and mitigate device related first-use learning effects exclusion criteria: * not currently working in emergency medicine/trauma setting * no prior course completion (advance trauma and basic life support) prior to the commencement of the study, all eligible participants were required to provide their consent to participate. participants were then provided with a standardized hl2 headset and operational tutorial, and completed a qualitative questionnaire to assess their clinical experience and exposure to the technology. the tutorial, which was guided by the research team, included a practical induction providing fundamentals of use, how to make and receive calls, and how to use the clinical data assets provided. participants were also required to pass a competency test to ensure standardized basic technical competency and mitigate device-related first-use learning effects.
novel alpha glucan gi tolerability study (loris chronic)

Conditions: Healthy Volunteers

Summary: this study aims to evaluate the gastrointestinal tolerance of chronic consumption (7 days) of a novel alpha glucan compared to a rapidly available carbohydrate (glucose syrup).

this study will be randomized, double blind, placebo-controlled, single-center, and 3x3 crossover in design. eligible participants will be randomized to receive the below products in single dose and in different random sequence, as determined by the randomization system: 1. novel alpha glucan (80 g/day) 2. novel alpha glucan (180 g/day) 3. glucose syrup (180 g/day)

Eligibility criteria:
inclusion criteria: 1. male or female participant, 2. healthy status (based on anamnesis), 3. age between 18 and 65 years, 4. body mass index (bmi) between 18.5 and 29.9 kg/m2, 5. able to understand and sign informed consent form, 6. having a smartphone with android or ios version compatible with patient cloud application exclusion criteria: 1. fasting plasma glucose higher or equal to 6,1 mmol /l at screening, 2. type i and type 2 diabetes, 3. pregnant or lactating women, 4. known food allergy or intolerance to test products, 5. treatment with anorectic drugs, glucose-lowering drugs, steroids, medications known to affect glucose metabolism and/or gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption, 6. colonoscopy, irrigoscopy or other bowel cleansing procedures four weeks prior the test, 7. any concomitant medication potentially interfering with study procedures and assessment: such as antibiotics, antiacids, or other medications impacting transit time, 8. major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments, 9. abnormal bowel transit, history of a gastrointestinal disorder (e.g., inflammatory bowel disease, diverticular diseases, colon cancer), or history of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average or chronic or recurrent diarrhea with spontaneous bowel movements more often than 3 times daily, 10. recent episode of an acute gastrointestinal illness, 11. habitual consumption of more than four servings per day of high-fiber foods or extreme dietary habits (e.g. very low carbohydrate diet), 12. ongoing or recent weight loss interventions (e.g. dietary weight loss programs), 13. alcohol intake higher than 2 servings per day. a serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer, 14. score of "severe" symptom for any of the symptoms included in the gastrointestinal symptom questionnaire, 15. volunteer who cannot be expected to comply with the protocol, 16. family or hierarchical relationships with clinical innovation lab team.
stem cell transplantation for sickle cell anemia

Conditions: Sickle Cell Disease

Summary: this protocol will be investigating the use of stem cell transplantation, in related donors, to cure sickle cell disease. sickle cell disease is a recessive disorder caused by a point mutation that results in the substitution of valine for glutamic acid at the sixth position in the b-chain of hemoglobin. this leads to sickling of the red blood cells under many conditions, such as hypoxia, dehydration, and hyperthermia. the sickling leads to vaso-occlusion, which causes irreversible damage in almost all systems in the body, including the central nervous system (cns), lungs, heart, bones, eyes, liver, and kidneys.

primary objective: 1) to determine disease free survival (dfs) at two years after matched sibling transplant using bone marrow (bm) after a conditioning regimen consisting of distal timed alemtuzumab, fludarabine, and melphalan for patients 2-30 y/o secondary objectives: 1. overall survival 2. rate of neutrophil and platelet engraftment for bm 3. incidence of graft failure 4. incidence of grade ii-iv and grade iii-iv acute graft vs host disease (gvhd) 5. incidence of chronic gvhd 6. incidence of other transplant complications, such as veno-occlusive disease, central nervous system (cns) toxicity, and idiopathic pneumonia syndrome (ips) 7. incidence of reactivation of cmv, ebv, adenovirus, bk/jc virus 8. incidence of invasive fungal disease 9. time to immune reconstitution via monitoring of lymphocyte subpopulations and immunoglobulin levels

Eligibility criteria:
inclusion criteria: * patient eligibility 1) matched sibling donors (9-10/10 marrow/pbsc or 5-6/6 ucb (single or double) with a total tnc dose of greater than 5 x 107/kg recipient weight) 1. age 2-30 2. hb ss, s-thal0, s-thal+, sc 3. evidence of ongoing hemolysis: hb\ 5%, ldh \> 500, tb\>2 4. karnofsky/lansky score \>50 5. lvsf\>26% or lvef\>40% 6. dlco \>40% or o2 sat \>85% for those patients that can't perform pfts 7. gfr \>70 and serum creatinine \< 1.5 \* uln for age 8. alt and ast \< 5 x uln, direct bilirubin \<2 x uln 9. if the patient has been on chronic transfusion or has a ferritin \>1000, liver biopsy should be done and show no evidence of bridging fibrosis or cirrhosis * exclusion criteria 1. evidence of uncontrolled bacterial, viral, or fungal infection within one month prior to initiation of the conditioning regimen 2. pregnant or breastfeeding 3. hiv positive 4. written informed consent not obtained

Keywords: stem cell transplant sickle cell stem cell transplantation related unrelated
effectiveness of orally dosed emergency contraception in obese women - upa

Conditions: Obesity; Contraception

Summary: obese women are significantly more likely than their normal bmi counterparts to experience failure of orally-dosed emergency contraceptives. our preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed emergency contraceptives in obese women. more data is needed regarding emergency contraception containing ulipristal acetate. the overall project will be focused on both levonorgestrel (lng) - and ulipristal acetate (upa)-containing emergency contraception but this protocol registration is for the upa aspect of the study procedures.

emergency contraception (ec) provides a woman with an additional line of defense against unintended pregnancy following an act of unprotected intercourse. orally-dosed ec works by delaying ovulation and reduces the risk of pregnancy for a single act of unprotected intercourse by 50-70%. unfortunately, obese women are significantly more likely than their normal bmi counterparts to experience failure of orally-dosed ec and in some instances ec is equivalent to placebo. our preliminary data provides evidence for testing a dose escalation strategy in an effort to provide improved efficacy from orally-dosed ec in obese women. we hypothesize that increasing the dose of orally-dosed ec agents will normalize the pharmacokinetics resulting in the expected treatment effect (delay in follicle rupture) in obese women. in the overall proposal, we plan to perform detailed pharmacokinetic and pharmacodynamic studies of upa-based ec in obese women and expand upon our preliminary findings of lng-based ec. this protocol registration is for the upa aspect of the study procedures focused on the pharmacokinetics and pharmacodynamics of upa and will include a dose escalation intervention.

Eligibility criteria:
inclusion criteria: * generally healthy women * aged 18-35 years old * regular menses (every 21-35 days) experiencing an ovulatory screening cycle with a progesterone level of 3 ng/ml or greater * subjects must have a bmi of \>30kg/m2 and weight at least 80kg or more or a bmi \<25kg/m2 and a weight of less than 80kg. exclusion criteria: * metabolic disorders including uncontrolled thyroid dysfunction and polycystic ovarian syndrome * impaired liver or renal function * actively seeking or involved in a weight loss program (must be weight stable) pregnancy, breastfeeding, or seeking pregnancy * recent (within last 8 weeks) use of hormonal contraception * current use of drugs that interfere with metabolism of sex steroids * smokers.

Keywords: obesity body weight bmi emergency contraception levonorgestrel ulipristal acetate
evaluation of the six minute walk test and other instruments in heart failure

Conditions: Heart Failure; Autonomic Nervous System Imbalance; Heart Rate and Rhythm Disorders; Quality of Life

Summary: the purpose of this study is to assess functional capacity, quality of life and functioning of the autonomic nervous system in heart failure patients on beta-blocker treatment. the study hypothesis is that subjects who walk less distance, have lower quality of life and reduced heart rate variability during the six minute walk test.

heart failure and its treatment result in symptoms such as pulmonary or systemic congestion causing impairment to the effort, psychological and social commitment, and impact on quality of life.

Eligibility criteria:
inclusion criteria: * both sexes * different etiologies of heart failure * functional class i - iii (nyha) * left ventricular ejection fraction (lvef) ≤ 50% * no history of previous cardiac surgery * in return for medical evaluation at the amelio marques clinic, hospital de clinicas, federal university of uberlândia scheduled for the period from october 2012 to january 2013 * clinical stability observed by: heart rate, respiratory rate, blood pressure and arterial oxygen saturation exclusion criteria: * bad cognition compromising the understanding of tests * physical disability that compromise the performance in walk test * aortic aneurysm or any aortic deformity * patients with signs or symptoms of transient myocardial ischemia with angina pectoris and/or class iv by the canadian cardiovascular society classification * anomalous pressure behavior with hypertension \> 180/100 mmhg * orthostatic hypotension (decrease \> 15 mmhg ) with symptoms * arrhythmia with presence of complex ventricular extra systoles * tachycardia sinus at rest (hr \> 120 beats/min) * atrioventricular block of 2nd or 3rd degree * subjects with pacemakers or implantable cardioverter-defibrillator (icd) * functional class iv by the new york heart association * chronic organ dysfunction such as renal failure, respiratory or liver disease * active neoplasia over the past five years * commitment as general weakness, fever, other limiting factors (psychological, musculoskeletal) * feeling sick before the beginning of the six minute walk test: intolerable angina or dyspnea, cramps in legs, staggering gait, excessive sweating (diaphoresis), pallor or ashen skin or spo2 below 85% * voluntary desire of the patient to withdraw from research

Keywords: heart failure autonomic nervous system heart rate quality of life
quality of life in patients with nonmelanoma skin cancer

Conditions: Nonmelanoma Skin Cancer

Summary: the goal of this study is to learn more about the physical discomfort, sensory impairment, depression, anxiety, and interference with relationships, family, and work associated with nmsc via survey questions.

the purpose of this study is to learn more about the physical discomfort, sensory impairment, depression, anxiety, and interference with relationships, family, and work associated with nmsc via survey questions.

Eligibility criteria:
inclusion criteria: * patients with nonmelanoma skin cancer * 18 years of age exclusion criteria: * non-english speakers * minors